The Third Circuit Court of Appeals will decide whether the IRS can force Mylan (and by extension other ANDA filers) to treat a) legal expenses to prepare notice letters and b) legal expenses to defend against infringement suits after paragraph
ANDVA Advisor Blog
The ANDVA Advisor Blog, published by Carlson Caspers, focuses on legal issues related to pharmaceutical patent litigation, particularly involving the Hatch-Waxman Act and ANDA (Abbreviated New Drug Application) cases. It covers topics such as the tax treatment of litigation costs in ANDA cases, patent enablement and written description requirements under Section 112 of the Patent Act, challenges to patent listings in the FDA's Orange Book, and significant court decisions affecting patent validity and enforcement. The blog also discusses Supreme Court and Federal Circuit rulings impacting patent law, including enablement standards for genus claims and the implications for biosimilar and pharmaceutical companies.
Latest from ANDVA Advisor Blog - Page 6
The Practitioner’s Duty of Candor to the USPTO
The United States Patent and Trademark Office (“USPTO”) issued a notice to clarify disclosure duties owed to it entitled Duties of Disclosure and Reasonable Inquiry During Examination, Reexamination, and Reissue, and for Proceedings Before the Patent Trial and Appeal Board…
Section VIII Statement Does Not Create “a Case or Actual Controversy” to Establish Subject Matter Jurisdiction for Declaratory Judgment Counterclaim
Judge Richard Andrews of the District of Delaware dismissed counterclaims lodged by two generic drug manufacturers, finding that no justiciable declaratory judgment controversy arises for an ANDA filer who only submits statements pursuant to 21 U.S.C. § 355(j)(2)(A)(viii) (“Section viii…
District Court Allows Infringement Claims to Proceed for Patent Issued After ANDA Approval
In a recent order, Judge John Bailey from the Western District of Virginia denied Defendant Mylan’s 12(b)(6) motion to dismiss § 271(e) infringement claims despite the USPTO issuing Plaintiff AstraZeneca’s patent after the FDA approved Mylan’s ANDA. AstraZeneca AB v.
Written Description Requirement for Negative Claim Limitations in Flux as Federal Circuit Panel Reverses Previous Panel Decision
Section 112 written description requirements present a challenge for patentees claiming negative limitations, as the extent to which a specification needs to disclose the absence of a feature is not entirely clear, especially following the recent Federal Circuit case Novartis…